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重度特应性皮炎患者使用度普利尤单抗的五年真实世界药物生存及其相关预测因素。

Five-year real-world drug survival of dupilumab in severe atopic dermatitis and associate predictors.

机构信息

Dermatology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy.

出版信息

J Dermatolog Treat. 2024 Dec;35(1):2404718. doi: 10.1080/09546634.2024.2404718. Epub 2024 Oct 13.

DOI:10.1080/09546634.2024.2404718
PMID:39396818
Abstract

BACKGROUND

Atopic dermatitis (AD) profoundly impacts patients' lives, necessitating long-term systemic treatments.

METHODS

This retrospective study involved 709 severe AD patients receiving dupilumab. Drug survival (DS) was analyzed using Kaplan-Meier curves, evaluating reasons for discontinuation. The log-rank test and Cox regression analysis were applied to assess differences in drug survival across baseline clinical characteristic groups.

RESULTS

Dupilumab showcased remarkable overall drug survival, reaching 74.1% at 65 months. Survival rates remained robust even when considering discontinuation solely due to primary or secondary inefficacy (86.4% at 65 months). For overall DS, the log-rank test did not reveal a statistically significant difference among the groups. Cox regression analysis showed that patients with nummular eczema-like as a phenotype have an increased risk of discontinuing dupilumab due to the development of psoriasis ( < .001, hazard ratio = 26.15, confidence interval [CI] 6.903-99.016). The multivariate logistic regression analysis confirmed these results ( < .001, OD = 18.956, CI 4.205-85.458), even when considering other clinical and epidemiological characteristics.

CONCLUSION

This investigation establishes dupilumab's enduring efficacy and safety in severe AD, emphasizing its potential as a sustained therapeutic option over 5+ years. Baseline characteristics did not seem to influence DS, with the exception of the nummular eczema-like phenotype, which emerged as a significant predictor of psoriasis occurrence.

摘要

背景

特应性皮炎(AD)深刻影响患者的生活,需要长期的系统治疗。

方法

这项回顾性研究涉及 709 名接受度普利尤单抗治疗的严重 AD 患者。使用 Kaplan-Meier 曲线分析药物生存(DS),评估停药原因。采用对数秩检验和 Cox 回归分析评估 DS 在基线临床特征组之间的差异。

结果

度普利尤单抗的整体药物生存情况显著,65 个月时达到 74.1%。即使仅考虑原发性或继发性疗效不佳导致的停药,生存率仍保持强劲(65 个月时为 86.4%)。对于总体 DS,对数秩检验未发现各亚组间有统计学差异。Cox 回归分析显示,具有钱币状湿疹样表型的患者因银屑病而停止使用度普利尤单抗的风险增加( < .001,风险比=26.15,置信区间 [CI] 6.903-99.016)。多变量逻辑回归分析证实了这些结果( < .001,OD=18.956,CI 4.205-85.458),即使考虑到其他临床和流行病学特征也是如此。

结论

本研究确立了度普利尤单抗在严重 AD 中的持久疗效和安全性,强调其作为一种持续治疗选择的潜力超过 5 年。除了钱币状湿疹样表型外,基线特征似乎不会影响 DS,而钱币状湿疹样表型是银屑病发生的一个显著预测因素。

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